Placebo Response on Attention-Deficit/Hyperactivity Disorder Ratings: Application to Multimodal Treatment Study of Attention-Deficit/Hyperactivity Disorder 3-Month Outcomes.

IF 2.2 4区医学 Q2 PEDIATRICS

Journal of child and adolescent psychopharmacology Pub Date : 2025-07-24 DOI:10.1177/10445463251360685

L Eugene Arnold, Hernan Bozzolo, Lindsay Crowl, Michael Yao, Ashley Jones Reno, Neha Dudipala, Antonino Amato, Lily Hechtman, Jeffrey Newcorn

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引用次数: 0

Abstract

Objective: To characterize the size and course of placebo response in attention-deficit/hyperactivity disorder (ADHD), with informant and moderator effects, and illustrate its importance by comparison to Multimodal Treatment Study of ADHD (MTA) 3-month data. Methods: In two randomized clinical trials parents and teachers rated DSM-IV ADHD symptoms (Sx) on pill placebo at baseline (BL), 8, 12, and 16 weeks for 57 children age 5-12 with ADHD (25 inattentive, 32 combined type) and on an intense 12-week nonmedical control condition (NMCC) for 27 children age 6-12. Results: Parent- and teacher-rated placebo effects peaked at 12 and 8 weeks, respectively. Changes from BL are significant (p = 0.001) by parent and teacher on inattentive Sx (d = .60, .56 for pill placebo; d = 1.48, .51 for NMCC) and on hyperactive/impulsive Sx by parent (d = 0.48 pill; d = 1.26 NMCC). Teacher-rated hyperactive/impulsive show greater placebo effect September-January than February-May (p = 0.017). Teacher-rated inattentive Sx shows a significant (p = 0.033) interaction of season*subtype. Compared to placebo data, MTA treatments show significant benefit (p = 0.000) at 3 months on both inattentive and HYP/IMP symptoms for medication management and combination groups but not for behavioral treatment (Beh) or community comparison groups, except for teacher-rated HYP/IMP for Beh (p = 0.002). Conclusions: Parent/teacher ratings show a medium placebo effect for pill placebo and a large effect (d > 1.2) by parent for intense, complex NMCC, suggesting that parent-rated placebo response depends on the complexity/intensity of the control condition. Raters agree on inattentive but diverge on HYP/IMP Sx. Teachers' perceptions of HYP/IMP severity change by season. Pill placebo data indirectly support the 3-month efficacy of two MTA treatments, combination and medication management.

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安慰剂对注意缺陷/多动障碍评分的影响：应用于注意缺陷/多动障碍3个月疗效的多模式治疗研究

目的：通过与ADHD多模式治疗研究（MTA） 3个月数据的比较，探讨ADHD患者安慰剂反应的大小和过程，以及安慰剂反应的提示效应和调节效应。方法：在两项随机临床试验中，57名5-12岁ADHD儿童（25名注意力不集中，32名混合型）的家长和教师在基线（BL）、8、12和16周对DSM-IV ADHD症状（Sx）进行药片安慰剂评分，27名6-12岁儿童在12周非医学对照条件（NMCC）下进行评分。结果：父母和老师评价的安慰剂效果分别在12周和8周达到顶峰。家长和教师在注意力不集中方面的BL变化显著（p = 0.001） (d = 0.60，药片安慰剂组为0.56；NMCC组d = 1.48， NMCC组d = 0.51)，父母对多动/冲动性Sx组d = 0.48；d = 1.26 NMCC)。教师评价的多动/冲动在9 - 1月比2 - 5月表现出更大的安慰剂效应（p = 0.017）。教师评定的注意力不集中Sx与季节*亚型的交互作用显著（p = 0.033）。与安慰剂数据相比，MTA治疗在3个月时对药物管理组和联合治疗组的注意力不集中和HYP/IMP症状均有显著益处（p = 0.000），但对行为治疗组（Beh）或社区对照组则没有显著益处（p = 0.002），除了Beh的教师评价HYP/IMP （p = 0.002）。结论：家长/老师评分显示，药丸安慰剂的安慰剂效应中等，而家长对强烈、复杂的NMCC的安慰剂效应较大（d > 1.2），这表明家长评价的安慰剂反应取决于对照条件的复杂性/强度。评级者一致认为“不专心”，但对HYP/IMP Sx的评价存在分歧。教师对HYP/IMP严重程度的看法随季节而变化。药丸安慰剂数据间接支持两种MTA治疗、联合用药和药物管理的3个月疗效。

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来源期刊

Journal of child and adolescent psychopharmacology 医学-精神病学

CiteScore

3.60

自引率

5.30%

发文量

审稿时长

>12 weeks

期刊介绍： Journal of Child and Adolescent Psychopharmacology (JCAP) is the premier peer-reviewed journal covering the clinical aspects of treating this patient population with psychotropic medications including side effects and interactions, standard doses, and research on new and existing medications. The Journal includes information on related areas of medical sciences such as advances in developmental pharmacokinetics, developmental neuroscience, metabolism, nutrition, molecular genetics, and more. Journal of Child and Adolescent Psychopharmacology coverage includes: New drugs and treatment strategies including the use of psycho-stimulants, selective serotonin reuptake inhibitors, mood stabilizers, and atypical antipsychotics New developments in the diagnosis and treatment of ADHD, anxiety disorders, schizophrenia, autism spectrum disorders, bipolar disorder, eating disorders, along with other disorders Reports of common and rare Treatment Emergent Adverse Events (TEAEs) including: hyperprolactinemia, galactorrhea, weight gain/loss, metabolic syndrome, dyslipidemia, switching phenomena, sudden death, and the potential increase of suicide. Outcomes research.